Tailored, Multidomain, and Coach-assisted Interactive Mobile Application for the Adoption and Maintenance of a Healthy Lifestyle in Middle-aged and Older Adults With Modifiable Risk Factors for Dementia: A Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Acceptability of randomization
研究概览
简要总结
The overarching aim is to develop and deploy a multidomain intervention delivered on a mobile application to help middle-aged to older adults reduce their risk for dementia by improving a set of modifiable lifestyle risk factors associated with cognitive decline/dementia. This registration concerns the Pilot Feasibility study which examines different aspects of feasibility in a small-scale randomized pilot study, before implementing an efficacy study on a larger sample. A secondary objective is to determine whether the program can result in a larger improvement on risk factors (measured with Behavioural Risk outcomes) compared to a control intervention. It is expected that persons enrolled in the Luci program show larger change in Behavioural Risk outcomes than those enrolled in the comparator condition.
详细描述
Multidomain lifestyle interventions show promising results in reducing the risk of cognitive decline and dementia.
In this study, we pilot the feasibility of a coach-based digital multidomain risk-reduction program to improve cognitive engagement, physical activity, and healthy eating in older adults at risk of dementia. This trial is the second step in the clinical validation process of the Luci program (see NCT04616794). In this 24-week study, participants are randomly assigned to the Luci Intervention group or to the Waiting-list Control group (i.e., participants receive the program after the end of the trial). Assessments will be done at study entry (T1), week 12 (T2), and week 24 (T3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Proficient or native speakers in French;
- •Computer literate defined as being able to read mails and browse the Internet, and having access to a computer, smartphone or tablet with an Internet connection;
- •Committed not to participate in another program related to any of the three intervention domains for the duration of the trial;
- •At least one of the following:
- •Low cognitive engagement in cognitively stimulating activities, defined as a score ≤ 22 on the adapted Cognitive Activity Questionnaire;
- •Low level of physical activity defined as less than 150 minutes/week) of moderate to vigorous physical activity measured using the Godin-Shephard Leisure Time Physical Activity Questionnaire, and no medical contraindication to physical activity based on the Physical Readiness Questionnaire for Everyone (PAR-Q+);
- •Low adherence to the Mediterranean-type diet defined as a score of ≤ 8 on the adapted Canadian Mediterranean Diet Scale, and no severe food allergy or intolerance or history of eating disorder.
排除标准
- •Presence of a cognitive impairment as measured by the Cogstate Brief BatteryTM.
- •General anesthesia within the last 6 months;
- •Participation in any previous validation studies related to the program;
- •Participation, currently or within the last 6 months, in a program where they received any of the three interventions;
- •Unable to commit participation over the period of the study.
- •Participants in the precontemplation stage of change.
- •Participants with a high level of perceived stress;
- •Having received a diagnosis of:
- •Dementia or neurodegenerative disease (AD and other dementias);
- •Past or present neurological disorder (multiple sclerosis, brain tumour, epilepsy, stroke, traumatic brain injury);
- •Severe psychiatric disorder (schizophrenia, major depression, bipolar disorder);
- •Uncontrolled cardiovascular or metabolic diseases;
- •Alcoholism or drug addiction;
- •Any other conditions expected to limit participation (e.g., visual acuity).
研究组 & 干预措施
Luci Intervention
Participants enrolled in this group will receive the Luci intervention for a 24-week period.
干预措施: Luci Coach Assisted Intervention (Behavioral)
Wait-list Control
Participants in the waiting-list control group will not receive any intervention during the study. They will be invited to participate to the program at the end of the trial.
结局指标
主要结局
Acceptability of randomization
时间窗: Week 24
Acceptability of randomization will be assessed by comparing the post-randomization dropout rate in the control group relative to the intervention group.
Retention rate
时间窗: Week 24
Retention rate will be calculated as the proportion of randomized participants completing at least one of the measures at study end.
Enrollment Ratio
时间窗: At baseline post-enrollment
Screening-to-enrollment ratio will be calculated as the number of enrolled participants over the number of screened participants.
Recruitment Rate
时间窗: At baseline post-randomization
Recruitment rate will be calculated as the number of participants randomized per month over the recruitment period
Program adherence
时间窗: Week 24
Program adherence will be calculated as the number of participants from the Luci condition who attend at least 66% of the prescribed coaching sessions over the 24-week intervention period.
次要结局
- Change from baseline in Cognitive Engagement(At baseline, week 12, week 24)
- Change from baseline in Mediterranean Diet Adherence(At baseline, week 12, week 24)
- Overall User Experience (Luci Coach Assisted Intervention condition only)(Week 24)
- Change from baseline in Cognitive Performance(At baseline, week 24)
- Change from baseline in Depression(At baseline, week 24)
- Change from baseline in Quality of Life(At baseline, week 24)
- Change from baseline in Dementia Literacy(At baseline, week 24)
- Change from baseline in Luci Medi Diet Adherence Score(At baseline, week 12, week 24)
- Change from baseline in Readiness to Change (Luci Coach Assisted Intervention condition only)(At baseline, week 24)
- Change from baseline in Current memory concerns(At baseline, week 24)
- Goal Attainment (Luci Coach Assisted Intervention condition only)(On a weekly basis from week 1 to 12, and every 2 weeks from week 13 to 24)
- Action Taken(At baseline, week 24)
- Change from baseline in Sleep Quality(At baseline, week 24)
- Change from baseline in Physical Activity(At baseline, week 12, week 24)
- Change from baseline in Sitting Time(At baseline, week 12, week 24)
- Change from baseline in Luci Cognitive Engagement Score(At baseline, week 12, week 24)
- Change from baseline in Luci Physical Activity Score(At baseline, week 12, week 24)
- Perceived Progress(Week 12, week 24)
- Change from baseline in Expectation (Luci Coach Assisted Intervention condition only)(At baseline, week 24)
- Platform Usage(Continuously from baseline until week 24)
- Change from baseline in Perceived Stress(At baseline, week 24)